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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00124-1
Product Name/Description OM040R - Doyen-Collin Mouth Gag 120mm

Produced between Feb 2016 and Oct 2017 inclusive

ARTG Number: 99164
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 14/03/2018
Responsible Entity B Braun Australia Pty Ltd
Reason/Issue Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.
It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. Instead of the specified material silicone, the material PVC was used for the manufacturing of the sleeves. This could render affected instruments unusable after reprocessing.
Recall Action Product Defect Correction
Recall Action Instructions B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.

This action has been closed out on the 16/11/2018.
Contact Information 1800 251 705 - B Braun Australia